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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06451263
Other study ID # 854677
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 19, 2024
Est. completion date May 31, 2025

Study information

Verified date June 2024
Source Abramson Cancer Center at Penn Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ovarian cancer lacks an effective screening test, and prompt treatment at diagnosis is the only way to improve outcomes. Referral to gynecologic oncology at diagnosis of adnexal mass is recommend by guidelines from every major medical organization. Yet, 1 in 4 patients with ovarian cancer nationwide and at Penn Medicine never see a gynecologic oncologist. Even when referred to gynecologic oncology, patients from historically-marginalized groups have twice as long duration from diagnosis to seeing gynecologic oncology. In this project, the investigators will pilot a clinician nudge to gynecologic oncology referral and compare the impact to historical controls.


Description:

The study consists of one intervention, a clinician nudge to gynecologic oncology referral. Referral to gynecologic oncology is recommended when patients are diagnosed with a complex adnexal mass on imaging (i.e., Ovarian-Adnexal Reporting and Data System [O-RADS] 4 or 5 on ultrasound or Magnetic Resonance Imaging [MRI]). When patients are identified as having a complex adnexal mass, the order will be pended by the clinical research coordinator and sent to the ordering provider with a message to sign. The message will include content about national guidelines on referral to gynecologic oncology with opt-out framed language.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date May 31, 2025
Est. primary completion date April 24, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women ages 18 years or older - Adnexal mass identified on imaging (i.e., O-RADS 4 or 5 on ultrasound or MRI, Codex 4 or 5 on CT scan) ordered by Penn Medicine clinician Exclusion Criteria: - Known diagnosis of ovarian cancer - Patient already established in gynecologic oncology

Study Design


Intervention

Behavioral:
Nudge
Referral to gynecologic oncology is recommended when patients are diagnosed with a complex adnexal mass on imaging (i.e., O-RADS 4 or 5 on ultrasound or MRI, Codex 4 or 5 on CT). When patients are identified as having an adnexal mass, the order will be pended by the clinical research coordinator and sent to the ordering provider with a message to sign. The order will be pended within 48 hours of resulting imaging. The message will include content about national guidelines on referral to gynecologic oncology with opt-out framed language.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adoption The primary implementation outcome is adoption, operationalized as the proportion of patients who are referred to gynecologic oncology within 30 days of diagnosis by study arm, to be evaluated overall and for historically marginalized patients. 30 days
Secondary Gyn Onc Visits The proportion of patients completing gynecologic oncology visits for surgical evaluation. 90 days
Secondary Gyn Onc Visits Time to first gynecologic oncology visit (in days from radiologic or pathologic diagnosis), also to be evaluated overall and for historically marginalized patients. 90 days
Secondary Adherence to Treatment Adherence to evidence-based treatment within 365 days of patient follow-up. 365 days
Secondary Progression Free and Overall Survival Progression-free and overall survival within 365 days of patient follow-up. 365 days
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